Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer

Completed

• Conditions: Lung Neoplasm; Lung Carcinoma; Malignant Lung Neoplasm

• Registration Number: NCT00899782
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

This research studies collecting and storing tissue and blood samples from patients with lung cancer who are undergoing surgery. Collecting and storing samples of tissue and blood from patients with lung cancer to study in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed Description

OBJECTIVES:

1. To collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality DNA, messenger ribonucleic acid (mRNA) and protein for molecular analysis.

2. To collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers.

3. To associate these specimens with historical, clinical, pathological, and outcome information.

Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the Cancer and Leukemia Group B (CALGB) Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.

Study Timeline

• Study Start: 2004-07-15
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2022-01
• Study Completion: 2022-02-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection and storage of frozen blood samples for the assessment of somatic mutations and levels of circulating markersto assess levels of circulating markers	Up to 5 years
Collection and storage of frozen tissue samples for molecular analysisor resection of lung cancer	Up to 5 years

Trial Locations

Locations (19)

Tunnell Cancer Center at Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Union Hospital of Cecil County; 🇺🇸 Elkton, Maryland, United States

Dana-Farber/Brigham and Women's Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia; 🇺🇸 Columbia, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Cancer Institute of New Jersey at Cooper - Voorhees; 🇺🇸 Voorhees, New Jersey, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

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